Differential Diagnosis Of Cancer And Other Conditions Based On Expression Of p63

Abstract

This invention relates to methods of distinguishing among various types of differentiated and undifferentiated epithelial carcinomas, and non-epithelial carcinomas, by detecting the presence of p63 nucleic acid or protein expression. The invention also provides methods for detecting p63 nucleic acids and proteins, as well as methods for diagnosing and treating certain tumors based on whether the tumors express p63.

1 - 24 . (canceled) 
     
     
         25 . A method for distinguishing a squamous cell tumor or a tumor of epithelial cells with squamous cell potential from a non-epithelial cell tumor or a glandular carcinoma without squamous differentiation or potential, which method comprises:
 testing a sample suspected of containing a tumor for p63 expression; and   classifying the sample as positive or negative for p63 expression, wherein a sample is considered positive only if the sample exhibits nuclear concentrations of p63, and   wherein positive p63 expression indicates that the sample contains a squamous cell tumor or a tumor of epithelial cells with squamous cell potential and the absence of p63 expression indicates that the tumor is a non-epithelial tumor or a glandular tumor without squamous differentiation or potential.   
     
     
         26 . The method according to  claim 25 , wherein the glandular carcinoma is a renal carcinoma. 
     
     
         27 . A method for distinguishing a squamous cell tumor or a tumor of squamous epithelia, transitional cells, or glandular epithelia with squamous cell potential from a non-epithelial cell tumor or a tumor without squamous differentiation or potential, which method comprises:
 testing a sample suspected of containing a tumor for p63 expression; and   classifying the sample as positive or negative for p63 expression, wherein a sample is considered positive only if the sample exhibits nuclear concentrations of p63, and   wherein positive p63 expression indicates that the sample contains a squamous cell tumor or a tumor of squamous epithelia, transitional cells or glandular cells with squamous cell potential and the absence of p63 expression indicates that the tumor is a non-epithelial tumor or a tumor without squamous differentiation or potential.   
     
     
         28 . The method according to  claim 25  wherein testing for p63 expression comprises detecting p63 protein. 
     
     
         29 . The method according to  claim 28 , wherein testing for p63 protein expression comprises detecting the p63 protein with an immunoassay. 
     
     
         30 . The method of  claim 29 , wherein the immunoassay is an immunohistochemical assay. 
     
     
         31 . A method of distinguishing a urothelial carcinoma from a non-epithelial cell tumor or a tumor without squamous differentiation or potential, which method comprises:
 testing a sample suspected of containing a tumor for p63 expression; and   classifying the sample as positive or negative for p63 expression, wherein a sample is considered positive only if the sample exhibits nuclear concentrations of p63, and   wherein positive p63 expression indicates that the sample contains a urothelial carcinoma and the absence of p63 expression indicates that the tumor is a non-epithelial tumor or a tumor without squamous differentiation or potential.   
     
     
         32 . A method of distinguishing a lung adenocarcinoma from a lung squamous carcinoma, comprising
 identifying a lung sample suspected of containing said lung adenocarcinoma or said lung squamous carcinoma as comprising tumor cells that are positive for p63 expression; and   determining whether said tumor cells exhibit a squamous carcinoma p63 staining pattern,   wherein p63 expression exhibiting said squamous carcinoma p63 staining pattern in said tumor cells indicates that said lung sample contains said lung squamous carcinoma and p63 expression in said tumor cells that does not exhibit said squamous carcinoma p63 staining pattern indicates that said lung sample contains said lung adenocarcinoma.   
     
     
         33 . The method of  claim 32  wherein said squamous carcinoma p63 staining pattern is a uniform nuclear staining of substantially all of said tumor cells. 
     
     
         34 . The method of  claim 32  wherein said squamous carcinoma p63 staining pattern is strong staining apparent in basalar, para-stromal areas lacking keritinization. 
     
     
         35 . The method according to  claim 27  wherein testing for p63 expression comprises detecting p63 protein. 
     
     
         36 . The method according to  claim 35 , wherein testing for p63 protein expression comprises detecting the p63 protein with an immunoassay.